Quality Manager: ISO 13485 & CAPA Leader

Medix™; Fort Collins (CO); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Profit sharing

Paid time off

Job summary

Medix in Fort Collins, CO is seeking a seasoned Quality Manager to lead the QMS function, ensuring compliance with ISO 13485 and GDP across the site.

You will own audits, CAPA, risk management, IQ/OQ/PQ validation, and supplier quality, while guiding a quality team and driving continuous improvement initiatives. Strong leadership and 5+ years in ISO-regulated manufacturing are required.

Qualifications

• Bachelor’s degree in Engineering, Quality, or Manufacturing.
• 5+ years quality management experience in ISO-regulated manufacturing.
• Minimum 3 years of management experience and 3+ years in controlled environments (medical device, aerospace, or automotive preferred).
• Technical skills include ISO 13485, eQMS/ERP, validation, and statistical methods.
• Certifications such as Six Sigma (Green/Black Belt), CQM, or CQA are preferred.

Responsibilities

• Maintain and optimize the eQMS to ensure ISO 13485 compliance and GDP.
• Lead internal, customer, and ISO certification audits; drive CAPA investigations.
• Oversee IQ/OQ/PQ validation, FMEA, calibration, and inspection standards.
• Serve as primary contact for supplier and customer quality concerns; monitor supplier quality.
• Track quality metrics and lead continuous improvement, waste reduction, and yield gains.
• Manage, coach, and develop quality staff; budgeting and performance reviews.
• Maintain Lean 6S safety and workplace standards.

Skills

Audit leadership

QMS management

CAPA & root cause

Lean 6S

Risk management

Leadership

Quality system compliance

Education

Bachelor's degree in Engineering/Quality/Manufacturing

Tools

eQMS/ERP software

Validation protocols

Blueprint reading

Statistics & SPC

Job description

Medix in Fort Collins, CO is seeking a seasoned Quality Manager to lead the QMS function, ensuring compliance with ISO 13485 and GDP across the site.

You will own audits, CAPA, risk management, IQ/OQ/PQ validation, and supplier quality, while guiding a quality team and driving continuous improvement initiatives. Strong leadership and 5+ years in ISO-regulated manufacturing are required.